Initial Submission: Letter from CIBA-GEIGY Corp. to USEPA re: Preliminary Results of Rangefinding Dietary Study in Dogs and Teratology Study in Rabbits with CGA-152005 dated 10/19/1990. (Declassified)

摘要

In a range finding rabbit teratology study conducted at oral doses of 0, 150, 300, 450 and 600 mg/kg, reduced food consumption, ataxia, and in more severely affected animals muscle atrophy, convulsions and death were observed. The incidence of these findings increased as a function of dose and appeared earlier (i.e., after fewer doses) in the high dose group. Fetal toxicity in surviving dams has not yet been evaluated. An additional study to be conducted at lower doses is being planned. In a range finding dog study conducted at feeding levels of 0, 500, 1000, 5000, 7500 or 10,000 ppm, severe treatment- related reduction in food consumption occurred at feeding levels of 5000 ppm and were accompanied by substantial reductions in hemoglobin levels, RBC count and hematocrit. The effects on hematologic parameters became apparent by week 3 and the humane sacrifice of some animals was necessary for males at levels 5000 ppm and for females at 10000 ppm. An evaluation of bone marrow from moribund sacrifice animals indicated the reduction of erythroid cell line. A study aimed at defining the no observable effect level (NOEL) is being planned. This compound is a research and development compound being evaluated for pesticidal purposes. These evaluations for pesticidal purposes are being conducted under the supervision of technically qualified personnel, knowledgeable in handling potentially hazardous chemicals.